A Single Dose Study Of PF-06678552 In Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Fed And Fasted Administration Of Single Escalating Oral Doses In Healthy Subjects

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06678552 or Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and/or female subjects of non childbearing potential.
• Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
• Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.	Drug: PF-06678552 or Placebo; PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
Experimental: Cohort 2; Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.	Drug: PF-06678552 or Placebo; PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
Experimental: Cohort 3; Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.	Drug: PF-06678552 or Placebo; PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).	0 to 72 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06678552	AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for for PF-06678552	Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06678552	Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06678552	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06678552	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06644927	AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06644927	Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06644927	Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Amount of PF-06644927 excreted in the urine (Ae)	Amount of drug excreted in the urine is a measure of the degree that the kidneys filter drug from the blood to the urine.	0-4, 4-12, and 12-24 hours post dose
Percent of PF-06678552 dose excreted in the urine as PF-06644927 (Ae%)	The percent of PF-06678552 dose excreted in the urine as PF-06644927 is calculated from the mass of dose excreted in the urine compared to the total dose of PF-06678552 and corrected for the relative weight of PF-06644927 to PF-06678552.	0-4, 4-12, and 12-24 hours post dose
Renal Clearance (CLr) for PF-06644927	Renal clearance is the measure of the rate of drug moving into the urine from blood	0-4, 4-12, and 12-24 hours post dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): March 28, 2014
• Last Update Submitted That Met QC Criteria: March 27, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: healthy subjects; Hypercholesterolemia; Lipid Metabolism Disorders; Metabolic Diseases; Dyslipidemias; Single Ascending Dose; Hyperlipidemias
• Other Study ID Numbers: B7611001